| Trial ID: | L3940 |
| Source ID: | NCT04992312
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| Associated Drug: |
Glucagon Nasal Powder [Baqsimi]
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| Title: |
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes
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| Acronym: |
RescuiNGkids
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| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04992312/results
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| Conditions: |
Type 1 Diabetes
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| Interventions: |
DRUG: Glucagon Nasal Powder [Baqsimi]
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| Outcome Measures: |
Primary: Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, A TEAE is defined as an adverse event which occurs post-dose or which is present prior to dosing and becomes more severe post-dose. An SAE is any AE from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more TEAEs, SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record., Baseline to Day 9 | Secondary: Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax), Change from baseline in BGmax was measured to investigate the PD effect of nasal glucagon on blood glucose level following 3 mg nasal glucagon administration on day 1. Baseline is defined as Day 1 pre-dose. The BGmax on Day 1 was determined using plasma samples collected pre-dose, 10, 30, 60, and 90 minutes post nasal glucagon dose., Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)|PD: Absolute BGmax of Nasal Glucagon, PD: Absolute BGmax of Nasal Glucagon, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)|PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon, PD: TBGmax of Nasal Glucagon, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)|PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose, AUC from time 0 to the last measured concentration of blood glucose at 90 minutes \[AUC(0-90)\] is reported., Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)|Pharmacokinetics (PK): AUC of Nasal Glucagon, PK: AUC of Nasal Glucagon, Day 1 (10, 30, 60 minutes post-dose)
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| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
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| Gender: |
ALL
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| Age: |
CHILD
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| Phases: |
PHASE1
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| Enrollment: |
7
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
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| Start Date: |
2022-03-24
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| Completion Date: |
2023-11-05
|
| Results First Posted: |
2024-05-23
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| Last Update Posted: |
2024-05-23
|
| Locations: |
Nemours Childrens Clinic, Jacksonville, Florida, 32207, United States|St. Luke's Regional Medical Center, Boise, Idaho, 83712, United States|Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|University of Minnesota Medical School, Minneapolis, Minnesota, 55454, United States|Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|UBMD Pediatrics, Buffalo, New York, 14203, United States|Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04992312
|
